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Estradiol Assay Kit (Magnetic Microparticle Chemiluminescence Method) - NMPA Registration 京械注准20242400142

Access comprehensive regulatory information for Estradiol Assay Kit (Magnetic Microparticle Chemiluminescence Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400142 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on April 02, 2024.

This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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NMPA Official Data
Class II
京械注准20242400142
Estradiol Assay Kit (Magnetic Microparticle Chemiluminescence Method)
雌二醇测定试剂盒（磁微粒化学发光法）
NMPA Registration Number: 京械注准20242400142
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Intended Use
English

用于体外定量测定人血清、血浆样本中的雌二醇（Estradiol）的含量。

Device Classification
Device Class
Class II
Model Specifications
25 tests/box, 2; 25 tests/box, 50 tests/box, 2; 50 tests/box, 100 tests/box, 2; 100 tests/box, 200 tests/box
25测试/盒、2;25测试/盒、50测试/盒、2;50测试/盒、100测试/盒、2;100测试/盒、200测试/盒
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20242400142
Approval Date
April 02, 2024
Expiry Date
April 01, 2029
Registrant
Name
Beijing Lepu Medical Technology Co., Ltd.
北京乐普诊断科技股份有限公司
Province/Region
Beijing
北京
Address
No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路37号
Production Facility
Production Address
北京市昌平区利祥路6号4幢、5幢、6幢
Structure and Composition
English

名称包装规格/装量主要组成成分及含量25测试/盒2;25测试/盒50测试/盒2;50测试/盒100测试/盒2;100测试/盒200测试/盒试剂1（R1）3.0mL/瓶;13.0mL/瓶;24.5mL/瓶;14.5mL/瓶;27.0mL/瓶;17.0mL/瓶;212.5mL/瓶;1偶联E2抗体的链霉亲和素磁性微粒试剂2（R2）3.0mL/瓶;13.0mL/瓶;24.5mL/瓶;14.5mL/瓶;27.0mL/瓶;17.0mL/瓶;212.5mL/瓶;1吖啶磺酰胺（AE）标记的E2抗原试剂3（R3）3.0mL/瓶;13.0mL/瓶;24.5mL/瓶;14.5mL/瓶;27.0mL/瓶;17.0mL/瓶;212.5mL/瓶;1雌二醇解离剂，含1%牛血清白蛋白的10mMPB缓冲液试剂4（R4）3.5mL/瓶;13.5mL/瓶;25.5mL/瓶;15.5mL/瓶;29.5mL/瓶;19.5mL/瓶;217.0mL/瓶;1样本稀释液，含1%牛血清白蛋白的10mMPB缓冲液校准品（选配1）1mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;61mL/瓶;620mMPB缓冲液，6个水平的校准品各1瓶，含有E2抗原，目标浓度20pg/mL，50pg/mL，125pg/mL，500pg/mL，1500pg/mL，3000pg/mL校准品（选配2）0.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;60.5mL/瓶;620mMPB缓冲液，6个水平的校准品各1瓶，含有E2抗原，目标浓度20pg/mL，50pg/mL，125pg/mL，500pg/mL，1500pg/mL，3000pg/mL校准品（选配3）1mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;31mL/瓶;320mMPB缓冲液，3个水平的校准品各1瓶，含有E2抗原，目标浓度50pg/mL，500pg/mL，1500pg/mL校准品（选配4）0.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;30.5mL/瓶;320mMPB缓冲液，3个水平的校准品各1瓶，含有E2抗原，目标浓度50pg/mL，500pg/mL，1500pg/mL质控品（选配1）1mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;21mL/瓶;220mMPB缓冲液，2个水平的质控品各1瓶，含有E2抗原，目标浓度50pg/mL，1000pg/mL质控品（选配2）0.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;20.5mL/瓶;220mMPB缓冲液，2个水平的质控品各1瓶，含有E2抗原，目标浓度50pg/mL，1000pg/mL

Storage Conditions and Expiration
English

Store at 2°C~8°C, valid for 18 months.

中文

2℃～8℃保存，有效期为18个月。